G1 Therapeutics Provides First Quarter 2019 Corporate and Financial Update
- Plans to submit U.S. and European marketing applications for trilaciclib following regulatory feedback
- First clinical data on oral SERD G1T48 expected in 3Q19
- Management to host webcast and conference call today at
4:30 p.m. ET
“Following meetings with regulatory authorities, we have clarity on a path to submitting marketing applications in the U.S. and
Raj Malik, M.D., Chief Medical Officer added, “Trilaciclib is the first in a deep pipeline of clinical-stage programs with near-term data readouts expected. We anticipate presenting new data on our next two programs – lerociclib and G1T48 – later this year. Based on promising early results in our Phase 1 clinical trial of G1T48 in ER+ breast cancer, we plan to present proof-of-concept data in the third quarter.”
Clinical, Operational and Executive Team Updates
- Plan to submit U.S. and European regulatory filings for trilaciclib: The company announced plans to submit marketing applications in the U.S. and
Europefor trilaciclib for myelopreservation in small cell lung cancer (SCLC) based on written feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration( FDA) and discussions with European regulatory authorities. G1 intends to file a New Drug Application (NDA) with the FDAin 2020 and submit a Marketing Authorization Application (MAA) to the European Medicines Agency(EMA) subsequent to an NDA filing. Full press release available here.
- Executive team change:
Jennifer Moses, who has been with the company for four years and most recently served as Vice President, Finance, has been appointed Chief Financial Officer. Barclay “Buck” Phillips, who had served as CFO and Senior Vice President, Corporate Development since 2017, departed the company to pursue other interests and opportunities.
- First investor day presentation: The G1 management team provided a comprehensive overview of the company’s three clinical development programs and outlined the commercialization strategy for trilaciclib. External experts
Jeffrey Crawford, M.D., Co-director, Solid Tumor Therapeutics Program, Duke Cancer Institute and Lowell Hart, M.D., Scientific Director of Research, Florida Cancer Specialists and trilaciclib clinical trial investigator, discussed chemotherapy-induced myelosuppression and trilaciclib’s potential to protect the bone marrow from damage by chemotherapy and improve patient outcomes. The webcast is available on the G1 website here.
First Quarter 2019 Financial Highlights
- Cash Position: Cash, cash equivalents and short-term investments totaled
$347.8 millionas of March 31, 2019, compared to $369.3 millionas of December 31, 2018.
- Operating Expenses: Operating expenses were
$25.9 millionfor the first quarter of 2019, compared to $20.7 millionfor the first quarter of 2018. GAAP operating expenses include stock-based compensation expense of $3.8 millionfor the first quarter of 2019, compared to $1.6 millionfor the first quarter of 2018.
- Research and Development Expenses: Research and development (R&D) expenses for the first quarter of 2019 were
$18.1 million, compared to $17.3 millionfor the first quarter of 2018. The increase in expense was primarily due to an increase in clinical program costs and personnel costs due to additional headcount.
- General and Administrative Expenses: General and administrative (G&A) expenses for the first quarter of 2019 were
$7.8 million, compared to $3.4 millionfor the first quarter of 2018. The increase in expense was largely due to an increase in compensation due to headcount increase, increase in pre-commercialization activities, and an increase in professional fees and other administrative costs necessary to support our operations as a public company.
- Net Loss: G1 reported a net loss of
$24.0 millionfor the first quarter of 2019, compared to $20.4 millionfor the first quarter of 2018.
Anticipated Milestones for 2019
- Expect to complete pre-NDA meeting with the
- Report additional data from all four randomized Phase 2 trilaciclib clinical trials.
- Present proof-of-concept data from the Phase 1 clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD), in ER+ breast cancer in 3Q19.
- Present preliminary dose-escalation data from the Phase 1b clinical trial of lerociclib/Tagrisso® (osimertinib) in non-small cell lung cancer in 3Q19.
- Present additional data from the Phase 1b clinical trial of lerociclib/Faslodex® (fulvestrant) in ER+, HER2- breast cancer in 4Q19.
Webcast and Conference Call
The management team will host a webcast and conference call at
G1 is based in
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48 and the timing for next steps with regard to the trilaciclib marketing applications, and are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the Company’s filings with the
Head of Investor and Public Relations
|G1 Therapeutics, Inc.
Balance Sheet Data
|March 31,||December 31,|
|Cash and cash equivalents||$||347,797||$||369,290|
|Total stockholders’ equity||$||338,941||$||358,820|
|G1 Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except per share data)
|Three Months Ended March 31,|
|Research and development||18,080||17,347|
|General and administrative||7,801||3,378|
|Total operating expenses||25,881||20,725|
|Total other income, net||1,929||315|
|Net loss attributable to common stockholders||$||(23,952||)||$||(20,410||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.64||)||$||(0.70||)|
|Weighted average common shares outstanding, basic and diluted||37,396,980||29,360,470|
Source: G1 Therapeutics