G1 Therapeutics Provides Fourth Quarter and Full-Year 2019 Corporate and Financial Update
New Drug Application (NDA) submission for trilaciclib in small cell lung cancer on track for 2Q20
Trilaciclib selected for inclusion in I-SPY 2 breast cancer trial
Rintodestrant (G1T48) combination trial with palbociclib expected to initiate in 2Q20
Management to host webcast and conference call today at
“We achieved significant clinical and regulatory milestones across our pipeline in 2019. In 2020, our primary focus is the execution of our
Fourth Quarter Regulatory, Clinical and Corporate Highlights
- Initiated rolling NDA submission for trilaciclib in small cell lung cancer (SCLC) in 4Q19 and expect to complete the filing in 2Q20. Certain portions of the NDA, including preclinical data, were submitted to the
U.S. Food and Drug Administration(FDA) in the fourth quarter of 2019. The company plans to complete the filing in the second quarter of 2020.
- Trilaciclib included in I-SPY 2 neoadjuvant breast cancer trial based on compelling overall survival (OS) findings in Phase 2 triple-negative breast cancer (TNBC) trial. At the
European Society for Medical Oncology(ESMO) 2019 Congress, the company presented preliminary data from its randomized, open-label Phase 2 trial of trilaciclib in TNBC showing that the addition of trilaciclib to chemotherapy resulted in a significant increase in OS compared to chemotherapy alone (press release here). These findings contributed to trilaciclib being selected for inclusion in the ongoing Phase 2 I-SPY 2 TRIAL™. Two new investigational treatment arms of the trial will evaluate trilaciclib in neoadjuvant treatment of locally advanced breast cancer. The study will generate data that will allow the company to evaluate trilaciclib in combination with several broadly-used chemotherapy classes, an anti-PD-1 immunotherapy, and a range of breast cancer subtypes (press release here).
- Findings from Phase 1/2a rintodestrant monotherapy trial in patients with ER+, HER2- breast cancer support initiation of combination trials with CDK4/6 inhibitors. The company announced preliminary safety, tolerability and efficacy data on rintodestrant (formerly G1T48), its oral selective estrogen receptor degrader (SERD), at the 2019
European Society of Medical Oncology Congressin September (press release here). Based on these findings, G1 plans to initiate an additional arm of its ongoing Phase 1/2a trial in the second quarter of 2020 to explore the combination regimen of rintodestrant and the CDK4/6 inhibitor Ibrance® (palbociclib) as a treatment for ER+, HER2- breast cancer. Palbociclib will be provided by Pfizer Inc. under a non-exclusive clinical supply agreement.
- Reported additional data from Phase 1b/2a clinical trial of lerociclib in combination with fulvestrant for the treatment of ER+, HER2- breast cancer. Updated findings presented at the 2019 San Antonio Breast Cancer Symposium showed lerociclib, dosed without a drug holiday, has a differentiated safety and tolerability profile than observed in clinical trials with currently marketed CDK4/6 inhibitors. Preliminary efficacy findings were consistent with other CDK4/6 inhibitors used in combination with fulvestrant. Additional safety and efficacy data are expected in the third quarter of 2020.
Fourth Quarter/Full-Year 2019 Financial Highlights and 2020 Guidance
- Cash Position: Cash and cash equivalents totaled
$269.2 millionas of December 31, 2019, compared to $369.3 millionas of December 31, 2018.
- Operating Expenses: Operating expenses were
$36.6 millionfor the fourth quarter of 2019, compared to $26.1 millionfor the fourth quarter of 2018. GAAP operating expenses include stock-based compensation expense of $4.5 millionfor the fourth quarter of 2019, compared to $3.3 millionfor the fourth quarter of 2018. Operating expenses for the full-year 2019 were $129.0 million, compared to $89.3 millionfor the prior year. Stock-based compensation expense for the full-year 2019 was $16.4 million, compared to $10.2 millionfor the prior year.
- Research and Development Expenses: Research and development (R&D) expenses for the fourth quarter of 2019 were
$24.5 million, compared to $19.1 millionfor the fourth quarter of 2018. R&D expenses for the full-year 2019 were $89.0 million, compared to $70.7 millionfor the prior year. The increase in R&D expenses was primarily due to an increase in clinical program costs, costs for manufacturing pharmaceutical active ingredients, and personnel costs due to additional headcount.
- General and Administrative Expenses: General and administrative (G&A) expenses for the fourth quarter of 2019 were
$12.1 million, compared to $7.0 millionfor the fourth quarter of 2018. G&A expenses for the full-year 2019 were $40.0 million, compared to $18.6 millionfor the prior year. 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
$35.4 millionfor the fourth quarter of 2019, compared to $24.1 millionfor the fourth quarter of 2018. Net loss for the full-year 2019 was $122.4 million, compared to a net loss of $85.3 millionfor the prior year.
- 2020 Guidance: The company expects to end 2020 with
$110-$130 millionin cash and cash equivalents, prior to the consideration of potential proceeds from partnerships, collaboration activities, and/or other sources of capital. The company expects year-end 2019 cash and cash equivalents of $269.2 millionto be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2021.
Key Anticipated 2020 Milestones
- Complete NDA submission for trilaciclib in SCLC in 2Q20 and Marketing Authorization Application to the
European Medicines Agencyin 4Q20.
- Begin enrollment in I-SPY 2 clinical trial of trilaciclib in neoadjuvant breast cancer in 2Q20.
- Initiate additional arm of rintodestrant Phase 1/2a trial to evaluate combination with Ibrance® (palbociclib) in 2Q20; additional Phase 1/2a monotherapy data expected in 4Q20.
- Initiate Phase 3 clinical trial of trilaciclib in colorectal cancer in 4Q20.
Webcast and Conference Call
The management team will host a webcast and conference call at
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the
Senior Director, Investor Relations & Corporate Communications
Balance Sheet Data
|Cash and cash equivalents||$||269,208||$||369,290|
|Total stockholders’ equity||$||255,527||$||358,820|
Condensed Statements of Operations
(in thousands, except per share data)
|Three Months Ended
|| Twelve Months Ended
|Research and development||24,492||19,077||89,002||70,683|
|General and administrative||12,061||7,009||40,039||18,603|
|Total operating expenses||36,553||26,086||129,041||89,286|
|Other income (expense)|
|Total other income, net||1,112||1,994||6,594||3,998|
|Net loss per share, basic and diluted||$||(0.94||)||$||(0.65||)||$||(3.27||)||$||(2.56||)|
|Weighted average common shares outstanding, basic and diluted||37,586,218||37,203,233||37,499,256||33,316,719|
Source: G1 Therapeutics