G1 Therapeutics Provides Third Quarter 2020 Corporate and Financial Update
- New Drug Application (NDA) for trilaciclib in small cell lung cancer accepted for Priority Review with a PDUFA action date of
- Announced CEO succession plan in evolution to commercial-stage company
- Management to host webcast and conference call today at 4:30 p.m. ET
“Since I joined G1 in 2014, the company has made tremendous progress in advancing trilaciclib from the lab to receiving Priority Review for our NDA and a PDUFA action date of
Regulatory, Clinical and Corporate Highlights
- NDA for trilaciclib in small cell lung cancer (SCLC) accepted by FDA and assigned Priority Review in
August 2020. The application was supported by positive data from three randomized clinical trials showing the myelopreservation benefits of trilaciclib in patients with SCLC being treated with chemotherapy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2021 (press release here). Trilaciclib has also received Breakthrough Therapy Designation by the FDA.
- Additional analyses of trilaciclib SCLC trial results presented at
North America Conference on Lung Cancer(NACLC). A mini-oral session highlighted analysis of three randomized trials in patients with small cell lung cancer that showed trilaciclib significantly reduced hospitalizations caused by chemotherapy-induced myelosuppression or sepsis.
- Completed enrollment in rintodestrant/palbociclib combination trial in
October 2020. The company expects preliminary safety, tolerability and efficacy data from 40 patients enrolled in this Phase 2 trial to be presented in the second quarter of 2021. The trial is comparing a treatment regimen of rintodestrant plus palbociclib (known commercially as Ibrance®) to fulvestrant plus palbociclib in patients with ER+, HER2- breast cancer.
- CEO succession plan announced in
September 2020. Effective January 1, 2021, Mark Velleca, M.D., Ph.D., will transition to the role of senior advisor and continue to serve as a member of the G1 Board of Directors. John (“Jack”) Bailey, a member of the company’s board, has been named as CEO (press release here).
“I’m excited to have the opportunity to lead G1 through its next chapter as a commercial company,” said
Third Quarter 2020 Financial Highlights and 2020 Guidance
- Cash Position: Cash and cash equivalents totaled
$238.3 millionas of September 30, 2020, compared to $269.2 millionas of December 31, 2019.
- License Revenue: License revenues were
$26.6 millionfor the third quarter of 2020, mostly related to the upfront cash payments from license agreements of $20.0 millionand $6.0 millionfrom EQRx, Inc.and Genor Biopharma, Inc., respectively.
- Operating Expenses: Operating expenses were
$36.3 millionfor the third quarter of 2020, compared to $34.0 millionfor the third quarter of 2019. GAAP operating expenses include stock-based compensation expense of $4.9 millionfor the third quarter of 2020, compared to $4.4 millionfor the third quarter of 2019.
- Research and Development Expenses: Research and development (R&D) expenses for the third quarter of 2020 were
$17.9 million, compared to $22.9 millionfor the third quarter of 2019. The decrease in R&D expenses was primarily due to a decrease of $4.6 millionin costs for manufacturing active pharmaceutical ingredients, as well as a decrease of $1.6 millionin external costs related to discovery and pre-clinical costs development. The decrease is partially offset by an increase of $1.2 millionin spend for clinical trials.
- General and Administrative Expenses: General and administrative (G&A) expenses for the third quarter of 2020 were
$18.4 million, compared to $11.1 millionfor the third 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, and an increase in professional fees and other administrative costs necessary to support our commercial operations.
- Net Loss: G1 reported a net loss of
$11.7 millionfor the third quarter of 2020, compared to $32.4 millionfor the third quarter of 2019.
- 2020 Guidance: The company has updated its cash and cash equivalents guidance provided in the second quarter, and now expects to end 2020 with cash and cash equivalents of
$200-$205 million(previous guidance of $185-$200 million). This guidance does not include consideration of potential additional proceeds from partnerships, collaboration activities and/or other sources of capital.
Key Anticipated 2020/2021 Milestones
- Initiation of Phase 3 trilaciclib metastatic colorectal cancer clinical trial in November/
- Presentation of additional Phase 2 data of trilaciclib in triple-negative breast cancer at the San Antonio Breast Cancer Summit (SABCS) in
- Presentation of additional rintodestrant monotherapy data at SABCS in
- Pending FDA approval, commercial launch of trilaciclib in SCLC in 1Q21.
- Presentation of rintodestrant/palbociclib Phase 2 data in 2Q21.
Webcast and Conference Call
The management team will host a webcast and conference call at
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the
Senior Director, Investor Relations & Corporate Communications
Balance Sheet Data
|Cash and cash equivalents||$||238,342||$||269,208|
|Total stockholders’ equity||$||197,472||$||255,527|
Condensed Statements of Operations
(in thousands, except per share data)
|Three Months Ended
|| Nine Months Ended
|Research and development||17,932||22,941||56,897||64,510|
|General and administrative||18,412||11,083||44,230||27,979|
|Total operating expenses||36,344||34,024||101,127||92,489|
|Loss from operations||(9,745||)||(34,024||)||(72,388||)||(92,489||)|
|Other income (expense):|
|Other income (expense)||(291||)||—||(488||)||14|
|Total other income (expense), net||(998||)||1,660||(588||)||5,483|
|Loss before income taxes||(10,743||)||(32,364||)||(72,976||)||(87,006||)|
|Income tax expense||931||—||931||—|
|Net loss per share, basic and diluted||$||(0.31||)||$||(0.86||)||$||(1.95||)||$||(2.32||)|
|Weighted average common shares outstanding, basic and diluted||38,009,204||37,540,380||37,819,071||37,469,952|
Source: G1 Therapeutics