G1 Therapeutics Provides Third Quarter 2019 Corporate and Financial Update
- Company to complete New Drug Application (NDA) submission for trilaciclib in small cell lung cancer in 2Q20
- Phase 2 trilaciclib data and Phase 1 G1T48 data presented at
- Management to host webcast and conference call today at
4:30 p.m. ET
“Based on written feedback from the
Third Quarter Regulatory and Clinical Highlights
- The company plans to submit an NDA for trilaciclib in small cell lung cancer (SCLC) based on written feedback from
FDA. Based on written feedback from its pre-NDA meeting with the U.S. Food and Drug Administration( FDA) in September, the company will file an NDA for trilaciclib in SCLC. The company expects to complete the NDA submission in the second quarter of 2020. Earlier this year, trilaciclib received Breakthrough Therapy Designation (BTD) from the FDAbased on positive myelopreservation data in SCLC patients from three randomized Phase 2 clinical trials. The BTD program is designed to expedite development and review of drugs intended for serious or life-threatening conditions.
ESMOpresentations: data from Phase 2 clinical trials of trilaciclib in metastatic triple-negative breast cancer (mTNBC) and SCLC and data from Phase 1 clinical trial of G1T48 in ER+, HER2- breast cancer. In an oral presentation on data from a randomized Phase 2 trial of trilaciclib, preliminary overall survival (OS) results demonstrated that women with mTNBC lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone. Data were published simultaneously in The Lancet Oncology. The company also presented updated Phase 2 results in SCLC patients receiving trilaciclib and chemotherapy in combination with Tecentriq® (atezolizumab) (press release here) and the first clinical data on its oral selective estrogen receptor degrader (SERD), G1T48. Preliminary results from the ongoing Phase 1/2a dose-escalation trial of G1T48 in patients with estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer showed G1T48 was well tolerated and demonstrated evidence of anti-tumor activity in heavily pre-treated patients. Based on safety and tolerability findings in the Phase 1b portion of this trial, the company selected the 600 mg and 1,000 mg doses of G1T48 for evaluation in the ongoing Phase 2a portion (press release here).
Third Quarter 2019 Financial Highlights
- Cash Position: Cash, cash equivalents and short-term investments totaled
$299.9 millionas of September 30, 2019, compared to $369.3 millionas of December 31, 2018.
- Operating Expenses: Operating expenses were
$34.0 millionfor the third quarter of 2019, compared to $20.8 millionfor the third quarter of 2018. GAAP operating expenses include stock-based compensation expense of $4.4 millionfor the third quarter of 2019, compared to $3.3 millionfor the third quarter of 2018.
- Research and Development Expenses: Research and development (R&D) expenses for the third quarter of 2019 were
$22.9 million, compared to $15.9 millionfor the third quarter of 2018. The increase in R&D expense 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 third quarter of 2019 were
$11.1 million, compared to $4.9 millionfor the third quarter of 2018. The increase in G&A expense 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
$32.4 millionfor the third quarter of 2019, compared to $19.9 millionfor the third quarter of 2018.
- 2019 Guidance: The company expects to end the year with
$265-$270 millionin cash and cash equivalents.
- Begin rolling NDA submission for trilaciclib in SCLC in 4Q19, which the company expects to complete in 2Q20; submit Marketing Authorization Application to the
European Medicines Agencyin 2H20.
- Initiate clinical trials of trilaciclib in colorectal cancer and TNBC in 2020.
- Present additional data from the Phase 1b/2a clinical trial of lerociclib + Faslodex® (fulvestrant) at the 2019 San Antonio Breast Cancer Symposium (SABCS) on
December 11, 2019.
- Identify dose and schedule of lerociclib and G1T48 for pivotal trials in ER+, HER2- breast cancer.
Webcast and Conference Call
The management team will host a webcast and conference call at
G1 is based in
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, the therapeutic potential of trilaciclib, lerociclib and G1T48 and the timing for next steps with regard to the trilaciclib marketing applications, 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; the Company’s development of a CDK4/6 inhibitor to reduce chemotherapy-induced myelosuppression is novel, unproven and rapidly evolving and may never lead to a marketable product; 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.
Senior Director, Investor Relations & Corporate Communications
|G1 Therapeutics, Inc.
Balance Sheet Data
|September 30,||December 31,|
|Cash and cash equivalents||$||299,933||$||369,290|
|Total stockholders’ equity||$||286,119||$||358,820|
|G1 Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except per share data)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||22,941||15,873||64,510||51,605|
|General and administrative||11,083||4,949||27,979||11,595|
|Total operating expenses||34,024||20,822||92,489||63,200|
|Other income (expense)|
Total other income, net
|Net loss per share, basic and diluted||$||(0.86||)||$||(0.59||)||$||(2.32||)||$||(1.91||)|
|Weighted average common shares outstanding,
basic and diluted
Source: G1 Therapeutics