GTHX G1 Therapeutics Inc.

15.25
-0.4  -3%
Previous Close 15.65
Open 15.73
52 Week Low 8.8
52 Week High 41.8
Market Cap $579,722,696
Shares 38,014,603
Float 23,259,091
Enterprise Value $388,489,536
Volume 484,652
Av. Daily Volume 604,094
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Upcoming Catalysts

Drug Stage Catalyst Date
Lerociclib (G1T38) plus Faslodex
ER+ breast cancer
Phase 1b
Phase 1b
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Trilaciclib
Triple-negative breast cancer
Phase 2
Phase 2
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Rintodestrant (G1T48) and Ibrance
ER+, HER2- breast cancer
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Trilaciclib
Colorectal cancer
Phase 3
Phase 3
Phase 3 trial to commence 4Q 2020.
Trilaciclib - I-SPY 2
Neoadjuvant breast cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial initiated 2Q 2020.
Trilaciclib
Second/third-line small-cell lung cancer
NDA Filing
NDA Filing
NDA filing submitted in June 2020.
Trilaciclib plus Tecentriq
First-line small-cell lung cancer
Phase 2
Phase 2
Phase 2 data presented at ESMO September 29, 2019.

Latest News

  1. - Submitted New Drug Application (NDA) for trilaciclib in small cell lung cancer (SCLC)
    - Co-promotion agreement with Boehringer Ingelheim for U.S. trilaciclib launch
    - Partnership for trilaciclib in China and global out-licensing of lerociclib net a combined $40 million in upfront payments, up to $486 million in milestone payments, plus potential royalties
    - Secured $100 million credit facility to support trilaciclib development and commercialization
    - Increasing cash guidance for FY 2020 to $185-$200 million at year end
    - Management to host webcast and conference call today at 5:00 p.m. ET

    RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today provided a…

    - Submitted New Drug Application (NDA) for trilaciclib in small cell lung cancer (SCLC)

    - Co-promotion agreement with Boehringer Ingelheim for U.S. trilaciclib launch

    - Partnership for trilaciclib in China and global out-licensing of lerociclib net a combined $40 million in upfront payments, up to $486 million in milestone payments, plus potential royalties

    - Secured $100 million credit facility to support trilaciclib development and commercialization

    - Increasing cash guidance for FY 2020 to $185-$200 million at year end

    - Management to host webcast and conference call today at 5:00 p.m. ET

    RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the second quarter ended June 30, 2020.

    "We made substantial progress on a number of fronts in the first half of 2020, and sharpened our focus on bringing trilaciclib to patients in 2021. By forging four strategic collaborations and securing a flexible credit facility, we have achieved three important objectives: positioning G1 for a strong commercial launch of trilaciclib in the United States, providing global access to our therapies, and securing non-dilutive capital to support the continued development of trilaciclib in additional indications," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "We are now executing a comprehensive launch strategy for trilaciclib designed to raise awareness of the burden that chemotherapy-induced myelosuppression places on patients and the healthcare system, as well as implementing a robust development plan to evaluate the benefits of trilaciclib in additional tumor types and chemotherapy regimens."

    Regulatory, Clinical and Corporate Highlights

    • NDA for trilaciclib in small cell lung cancer (SCLC) submitted in June 2020. Pending acceptance, the company expects to receive a PDUFA date assignment by the U.S. Food and Drug Administration (FDA) in August 2020. Trilaciclib has been assigned Breakthrough Therapy Designation by the FDA.  
    • Entered into co-promotion agreement with Boehringer Ingelheim for trilaciclib in SCLC in the United States and Puerto Rico. Under the terms of the three-year agreement, G1 and Boehringer Ingelheim will collaborate on the commercialization of trilaciclib for its first potential indication in SCLC. G1 will lead marketing, market access and medical engagement initiatives, with Boehringer Ingelheim leading sales force engagement initiatives. G1 will book revenue and retain development and commercialization rights to trilaciclib (press release here).
    • Partnered with Simcere to develop and commercialize trilaciclib in Greater China. The company entered into an exclusive agreement with Simcere Pharmaceuticals Group for the development and commercialization of trilaciclib for all indications in Greater China (mainland China, Hong Kong, Macau, and Taiwan). Under the terms of the agreement, G1 received a $14 million upfront payment and is eligible to receive sales-based royalties and up to $156 million in potential milestone payments (press release here). As part of this agreement, the company will collaborate with Simcere on future clinical trials. G1 and Simcere will be responsible for all development and commercialization costs in their respective territories.
    • I-SPY 2 neoadjuvant breast cancer trial including trilaciclib initiated in 2Q20. Trilaciclib was selected for inclusion in the ongoing Phase 2 I-SPY 2 TRIAL™, based on compelling overall survival findings in a Phase 2 triple-negative breast cancer (TNBC) trial (press release here). The I-SPY trial will generate data across a range of breast cancer subtypes that will allow the company to evaluate trilaciclib in combination with several broadly-used chemotherapy classes and an anti-PD-1 immunotherapy. 
    • Rintodestrant and Ibrance combination trial initiated in 2Q20. The company previously announced preliminary safety, tolerability and efficacy data on rintodestrant, its oral selective estrogen receptor degrader (SERD) (press release here) as monotherapy treatment for ER+, HER2- breast cancer. Based on these findings, G1 initiated an additional arm of its ongoing Phase 1/2a trial to evaluate the combination regimen of rintodestrant and the CDK4/6 inhibitor Ibrance® (palbociclib). Palbociclib is being provided by Pfizer Inc. under a non-exclusive clinical supply agreement.
    • Out-licensed global development and commercialization rights to lerociclib. The company entered into separate, exclusive agreements with EQRx (rights for U.S., Europe, Japan, and all markets outside Asia-Pacific) and Genor Biopharma (rights for Asia-Pacific, excluding Japan) for the development and commercialization of lerociclib in all indications. Combined, these agreements provided $26 million in upfront payments to G1, along with sales-based royalties and up to $330 million in potential milestone payments (see press releases on EQRx agreement and Genor agreement). EQRx and Genor are responsible for all costs related to the development and commercialization of lerociclib in their respective territories.
    • Out-licensed global development and commercialization rights to preclinical CDK2 inhibitor compounds. The company entered into an exclusive license agreement with ARC Therapeutics for global development and commercialization rights to its preclinical CDK2 inhibitor compounds. Under the terms of the agreement, G1 received an upfront payment and equity in ARC with an aggregate value of approximately $2.1 million. The company is also entitled to receive an additional milestone payment and sales-based royalties, and has right of first negotiation to re-acquire these assets.
    • Secured flexible credit financing for up to $100 million. The company announced it had entered into a debt financing agreement for up to $100 million with Hercules Capital, Inc. G1 has accessed $20 million to support the development and commercialization of trilaciclib (press release here).

    Second Quarter 2020 Financial Highlights and 2020 Guidance

    • Cash Position: Cash and cash equivalents totaled $234.3 million as of June 30, 2020, compared to $269.2 million as of December 31, 2019.
    • License Revenue: License revenues were $2.1 million for the second quarter of 2020, related to the license of CDK2 inhibitor compounds to ARC Therapeutics.
    • Operating Expenses: Operating expenses were $33.0 million for the second quarter of 2020, compared to $32.6 million for the second quarter of 2019. GAAP operating expenses include stock-based compensation expense of $4.4 million for the second quarter of 2020, compared to $3.7 million for the second quarter of 2019.
    • Research and Development Expenses: Research and development (R&D) expenses for the second quarter of 2020 were $18.5 million, compared to $23.5 million for the second quarter of 2019. The decrease in R&D expenses was primarily due to a decrease in clinical program costs of $3.4 million and regulatory filing reimbursement received during the second quarter of 2020 for $3.0 million, offset by an increase in costs for manufacturing active pharmaceutical ingredients.
    • General and Administrative Expenses: General and administrative (G&A) expenses for the second quarter of 2020 were $14.4 million, compared to $9.1 million for the second quarter of 2019. The increase in G&A expenses was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, increase in medical affairs costs, and an increase in professional fees and other administrative costs necessary to support our operations.
    • Net Loss: G1 reported a net loss of $31.2 million for the second quarter of 2020, compared to $30.7 million for the second quarter of 2019.
    • 2020 Guidance: The company is increasing its previous financial guidance and expects to end 2020 with $185-$200 million in cash and cash equivalents, up from previous guidance of $110-$130 million. This guidance includes receipt of upfront payments from recent agreements, but does not include consideration of potential additional proceeds from partnerships, collaboration activities, and/or other sources of capital.

    Key Anticipated 2020 Milestones

    • NDA acceptance/PDUFA date assignment for trilaciclib in SCLC in August 2020.
    • Initiate Phase 3 clinical trial of trilaciclib in colorectal cancer in 4Q20.
    • Presentation of Phase 2 data of trilaciclib in triple-negative breast cancer in 4Q20.
    • Presentation of additional rintodestrant monotherapy data in 4Q20.

    Webcast and Conference Call

    The management team will host a webcast and conference call at 5:00 p.m. ET today to provide a corporate and financial update for the second quarter 2020 ended June 30, 2020. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 4648036. 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 G1 Therapeutics

    G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class FDA-designated Breakthrough Therapy designed to improve outcomes for patients being treated with chemotherapy. Rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

    G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

    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," "estimate," "intend" 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 relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, trilaciclib's possibility to improve patient outcomes across multiple indications, rintodestrant's potential to be best-in-class oral SERD, lerociclib's differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors, our reliance on partners to develop and commercial licensed products, and the impact of pandemics such as COVID-19 (coronavirus), 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 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 development-stage company; and market conditions. 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.

    Contact:

    Jeff Macdonald

    Senior Director, Investor Relations & Corporate Communications

    919-907-1944



     

    G1 Therapeutics, Inc.

    Balance Sheet Data

    (in thousands)
         
        June 30,   December 31,
       2020   2019 
         
    Cash and cash equivalents $  234,267  $  269,208 
    Working capital $  218,167  $  251,234 
    Total assets $  253,597  $  284,831 
    Accumulated deficit $  (399,086) $  (336,853)
    Total stockholders' equity $  203,845  $  255,527 

     



    G1 Therapeutics, Inc.

    Condensed Statements of Operations

    (in thousands, except per share data)
             
      Three Months Ended June 30,  Six Months Ended June 30,
       2020   2019   2020   2019 
    License revenue – related party $  2,140  $  —  $  2,140  $  — 
    Operating expenses:        
    Research and development    18,531     23,489     38,965   41,569  
    General and administrative    14,431     9,094     25,818     16,896 
    Total operating expenses    32,962     32,583     64,783     58,465 
    Loss from operations    (30,822)     (32,583)     (62,643)     (58,465) 
    Other income (expense):        
    Interest income    91     1,893     872     3,809 
    Interest expense  (265)     —   (265)    
    Other income (expense)  (214)     —   (197)   14 
    Total other income (expense), net    (388)     1,893     410     3,823 
    Net loss $  (31,210)  $  (30,690)  $  (62,233)  $  (54,642) 
    Net loss per share, basic and diluted$  (0.83)  $  (0.82)  $  (1.65)  $  (1.46) 
    Weighted average common shares outstanding, basic and diluted   37,786,208     37,470,926     37,722,965     37,434,156 

     

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  2. RESEARCH TRIANGLE PARK, N.C., Aug. 04, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today announced that Chief Executive Officer Mark Velleca, M.D., Ph.D. will present company updates at two investor conferences in August 2020:

    • BTIG Virtual Biotechnology Conference 2020 on Monday, August 10, 2020 at 11:30 a.m. ET
    • 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020 at 10:55 a.m. ET

    To access live and archived webcasts of the presentations, please visit the Events & Presentations page of the G1 website.

    About G1 Therapeutics
    G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies…

    RESEARCH TRIANGLE PARK, N.C., Aug. 04, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today announced that Chief Executive Officer Mark Velleca, M.D., Ph.D. will present company updates at two investor conferences in August 2020:

    • BTIG Virtual Biotechnology Conference 2020 on Monday, August 10, 2020 at 11:30 a.m. ET
    • 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020 at 10:55 a.m. ET

    To access live and archived webcasts of the presentations, please visit the Events & Presentations page of the G1 website.

    About G1 Therapeutics

    G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class FDA-designated Breakthrough Therapy designed to improve outcomes for patients being treated with chemotherapy. Rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

    G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

    Contact:

    Jeff Macdonald

    G1 Therapeutics, Inc.

    Senior Director, Investor Relations & Corporate Communications

    919-907-1944

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    • Simcere to lead clinical development, regulatory submissions and commercialization of trilaciclib across all indications in Greater China 
    • G1 to receive $14 million upfront payment, sales royalties and up to $156 million in future milestone payments

    RESEARCH TRIANGLE PARK, N.C., U.S, and NANJING, China, Aug. 03, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, and Simcere Pharmaceutical Group, a pharmaceutical company rapidly transitioning to an innovative and R&D-driven company in China, today announced an exclusive license agreement for the development and commercialization of trilaciclib across all indications in Greater China (mainland China, Hong Kong, Macau and Taiwan). Discovered and developed…

    • Simcere to lead clinical development, regulatory submissions and commercialization of trilaciclib across all indications in Greater China 

    • G1 to receive $14 million upfront payment, sales royalties and up to $156 million in future milestone payments

    RESEARCH TRIANGLE PARK, N.C., U.S, and NANJING, China, Aug. 03, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, and Simcere Pharmaceutical Group, a pharmaceutical company rapidly transitioning to an innovative and R&D-driven company in China, today announced an exclusive license agreement for the development and commercialization of trilaciclib across all indications in Greater China (mainland China, Hong Kong, Macau and Taiwan). Discovered and developed by G1, trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy.

    "Trilaciclib has the potential to be the first proactively administered myelopreservation therapy that can improve outcomes for patients receiving chemotherapy. We are excited to collaborate with Simcere, an established leader in innovative drug development and commercialization in China, to advance this new therapy in China," said Mark Velleca, M.D., Ph.D., Chief Executive Officer of G1. "Simcere has extensive experience conducting clinical trials and securing regulatory approvals in China, and an expansive commercial infrastructure that supports education and access. These strengths make them an important strategic partner for G1 to achieve our vision of bringing trilaciclib to patients around the world."

    Under the terms of the agreement, G1 will receive an upfront payment of $14 million and be eligible to receive up to $156 million in development and commercial milestone payments. Simcere will also pay G1 tiered low double-digit royalties on annual net sales of trilaciclib in Greater China. Simcere will have exclusive development and commercialization rights for trilaciclib for all indications in Greater China, and will participate in global clinical trials of trilaciclib. G1 retains development and commercialization rights to trilaciclib in all territories outside of Greater China. The companies will be responsible for all development and commercialization costs in their respective territories.

    Pin Wang, Ph.D., Chief Scientific Officer of Simcere, said: "Chemotherapy is the cornerstone therapy for cancer patients. China, as a major user of this treatment modality, has a considerable patient population who are suffering from myelosuppression caused by chemotherapy. We are delighted to form this alliance with G1 Therapeutics to develop and commercialize world's first-in-class investigational myelopreservation therapy, trilaciclib, in China. We look forward to further expanding its clinical value based on the unique mechanism of trilaciclib. It is hoped that through the joint efforts of both parties trilaciclib will soon address a key unmet medical need in the treatment of cancer patients globally."

    Lung cancer is the most common cancer worldwide, with small cell lung cancer accounting for approximately 15% of all lung cancer cases. According to the World Health Organization's (WHO) specialized cancer agency, the International Agency for Research on Cancer (IARC), there were almost 750,000 new lung cancer cases in China in 2018.

    About Trilaciclib

    Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Trilaciclib has received Breakthrough Therapy Designation based on myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy treatment in patient with small cell lung cancer (SCLC). In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. In June 2020, G1 submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for trilaciclib for myelopreservation in SCLC and began a study in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL. The company expects to initiate a registrational Phase 3 trial in colorectal cancer in the fourth quarter of 2020.

    About Simcere Pharmaceutical Group

    Simcere Pharmaceutical Group is rapidly transitioning to an innovation and R&D-driven pharmaceutical company, with a mission of "providing today's patients with medicines of the future." Continuously recognized as one of the "Top 10 Innovative Pharmaceutical Enterprises in China" and "Top 100 Pharmaceutical Manufacturing Enterprises of China," it has established three R&D centers in Nanjing, Shanghai and Boston (the United States), respectively; with the approval of the Ministry of Science and Technology, Simcere has also established a national key laboratory of translational medicine and innovative pharmaceuticals. Simcere focuses on oncology, central nervous system disease and autoimmune disease therapeutic areas, with a diversified product portfolio and industry-leading capabilities. Simcere has established a unique open innovation model, building up collaborative relationships with leading domestic and international pharmaceutical companies and biotechnology companies. Simcere aims to bring more global life science breakthroughs to China, in an effort to benefit more patients and boost the country's healthcare industry growth and development.

    About G1 Therapeutics

    G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class FDA-designated Breakthrough Therapy designed to improve outcomes for patients being treated with chemotherapy. Rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

    G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

    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," "estimate," "intend" 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 relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, trilaciclib's possibility to improve patient outcomes across multiple indications, rintodestrant's potential to be best-in-class oral SERD, lerociclib's differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors and the impact of pandemics such as COVID-19 (coronavirus), and are based on G1 Therapeutics' 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 G1 Therapeutics' actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics' filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, G1 Therapeutics' ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; G1 Therapeutics' 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 development-stage company; and market conditions. Except as required by law, G1 Therapeutics and Simcere Pharmaceutical Group assume no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    G1 Contacts:

    Jeff Macdonald

    Senior Director, Investor Relations & Corporate Communications

    919-907-1944

    Simcere Contacts:

    Jie Feng

    Investor Relations

    +86 13770677353

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  3. RESEARCH TRIANGLE PARK, N.C., July 29, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today announced that it will host a webcast and conference call to provide a corporate and financial update for the second quarter of 2020 on Wednesday, August 5, 2020 at 5:00 p.m. ET.

    The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 4648036. The live and archived webcast will be available on the Events & Presentations page of the G1 website.

    About G1 Therapeutics
    G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives…

    RESEARCH TRIANGLE PARK, N.C., July 29, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today announced that it will host a webcast and conference call to provide a corporate and financial update for the second quarter of 2020 on Wednesday, August 5, 2020 at 5:00 p.m. ET.

    The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 4648036. The live and archived webcast will be available on the Events & Presentations page of the G1 website.

    About G1 Therapeutics

    G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class FDA-designated Breakthrough Therapy designed to improve outcomes for patients being treated with chemotherapy. Rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

    G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

    Contact:

    Jeff Macdonald

    Senior Director, Investor Relations & Corporate Communications

    919-907-1944



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  4. - G1 to receive $20 million upfront payment, sales royalties and potential milestone payments of up to $290 million for commercialization of lerociclib in the U.S., Europe, Japan

    RESEARCH TRIANGLE PARK, N.C. and CAMBRIDGE, Mass., July 22, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today announced a license agreement for lerociclib to EQRx™, a biopharmaceutical company focused on making innovative medicines at dramatically lower prices for the benefit of people and society. Under the terms of the agreement, EQRx gains exclusive rights for lerociclib in the U.S., Europe, Japan and all other global markets, excluding the Asia-Pacific region (except Japan). G1 will receive an upfront cash…

    - G1 to receive $20 million upfront payment, sales royalties and potential milestone payments of up to $290 million for commercialization of lerociclib in the U.S., Europe, Japan

    RESEARCH TRIANGLE PARK, N.C. and CAMBRIDGE, Mass., July 22, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today announced a license agreement for lerociclib to EQRx™, a biopharmaceutical company focused on making innovative medicines at dramatically lower prices for the benefit of people and society. Under the terms of the agreement, EQRx gains exclusive rights for lerociclib in the U.S., Europe, Japan and all other global markets, excluding the Asia-Pacific region (except Japan). G1 will receive an upfront cash payment of $20 million and will be eligible to receive development and commercial milestone payments of up to $290 million, plus tiered royalties ranging from mid-single digits to mid-teens based on annual net sales of lerociclib.

    "We are excited to partner with EQRx to further development of lerociclib, a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies," said Mark Velleca, M.D., Ph.D., Chief Executive Officer of G1. "This is the third strategic collaboration we have executed this year. Collectively, these partnerships have advanced our goal to provide global access to our promising oncology therapies and extend our financial runway so that we can continue our efforts to bring novel treatments to patients with cancer."

    Discovered and developed by G1, lerociclib has demonstrated clinical proof-of-concept and a differentiated profile in a Phase 1/2 trial in patients with ER+, HER2- breast cancer. Earlier this year, G1 licensed development and commercialization rights in the Asia-Pacific region (excluding Japan) to Genor Biopharma.

    About Lerociclib

    Lerociclib is a differentiated oral CDK4/6 inhibitor being developed for use in combination with other targeted therapies in certain types of breast and lung cancer. Preliminary clinical data in estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer have demonstrated proof-of-concept of the differentiated clinical profile of lerociclib versus currently marketed CDK4/6 inhibitors, with improved tolerability and less neutropenia. Neutropenia is one of the main toxicities associated with CDK4/6 inhibition. Current treatments require frequent blood testing for neutropenia. Less monitoring would mean fewer office visits and blood draws, improving the experience for patients and reducing the burden on physician offices and costs to the healthcare system.

    About G1 Therapeutics

    G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class FDA-designated Breakthrough Therapy designed to improve outcomes for patients being treated with chemotherapy. Rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

    G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

    About EQRx

    EQRx™ is committed to making innovative medicines at dramatically lower prices for the benefit of people and society. By bringing together stakeholders from across the healthcare system and utilizing the latest advances in science and technology, the company seeks to discover, develop and deliver high-quality, patent-protected medicines more efficiently and cost-effectively than ever before. Headquartered in Cambridge, Massachusetts, the company is backed by GV, ARCH Venture Partners, Andreessen Horowitz, Casdin Capital, Section 32, Nextech, and Arboretum Ventures. For more information, please visit www.eqrx.com.

    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," "estimate," "intend" 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 relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, rintodestrant's potential to be best-in-class oral SERD, lerociclib's differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors and the impact of pandemics such as COVID-19 (coronavirus), and 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 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 development-stage company; and market conditions. 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.

    EQRx™ is a trademark of EQRx, Inc.



    Contact:

    Jeff Macdonald

    G1 Therapeutics, Inc.

    Senior Director, Investor Relations & Corporate Communications

    919-907-1944

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