G1 Therapeutics Provides First Quarter 2020 Corporate and Financial Update

• New Drug Application (NDA) submission for trilaciclib in small cell lung cancer on track for 2Q20
• Rintodestrant combination trial with palbociclib expected to initiate in 2Q20
• Management to host webcast and conference call today at 4:30 p.m. ET

RESEARCH TRIANGLE PARK, N.C., May 06, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the first quarter ended March 31, 2020.

“We have activated business continuity plans in response to the COVID-19 pandemic to ensure we can advance therapies that patients with cancer, their families, and healthcare providers are counting on to improve outcomes, and also taken actions to safeguard the well-being of our employees,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “We are on track to complete a New Drug Application filing for trilaciclib for patients with small cell lung cancer this quarter, and have initiated virtual medical education programs as we prepare for commercial launch in the U.S. We remain committed to evaluating the benefits of trilaciclib in other indications and expect to initiate the I SPY-2 breast cancer trial this quarter and a pivotal trial in colorectal cancer in the fourth quarter of 2020. Cancer patients experiencing chemotherapy-induced myelosuppression are an especially vulnerable population, and trilaciclib has the potential to be the first proactively administered myelopreservation therapy for these patients.”

First Quarter Regulatory, Clinical and Corporate Highlights

First Quarter 2020 Financial Highlights and 2020 Guidance

• Cash Position: Cash and cash equivalents totaled $242.4 million as of March 31, 2020, compared to $269.2 million as of December 31, 2019.
• Operating Expenses: Operating expenses were $31.8 million for the first quarter of 2020, compared to $25.9 million for the first quarter of 2019. GAAP operating expenses include stock-based compensation expense of $4.7 million for the first quarter of 2020, compared to $3.8 million for the first quarter of 2019.
• Research and Development Expenses: Research and development (R&D) expenses for the first quarter of 2020 were $20.4 million, compared to $18.1 million for the first quarter of 2019. 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 first quarter of 2020 were $11.4 million, compared to $7.8 million for the first 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 $31.0 million for the first quarter of 2020, compared to $24.0 million for the first quarter of 2019.
• 2020 Guidance: The company is reiterating its previous financial guidance and expects to end 2020 with $110-$130 million in cash and cash equivalents, prior to the consideration of potential proceeds from partnerships, collaboration activities, and/or other sources of capital. The company expects current cash and cash equivalents to be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2021.

Key Anticipated 2020 Milestones

• Complete NDA submission for trilaciclib in SCLC in 2Q20.
• Initiate 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 4:30 p.m. ET today to provide a corporate and financial update for the first quarter 2020 ended March 31, 2020. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 5669692. 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 therapy designed to improve outcomes for patients being treated with chemotherapy. Trilaciclib has received Breakthrough Therapy Designation from the FDA; a rolling NDA submission for small cell lung cancer is expected to be completed in the second quarter of 2020. 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), 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
jmacdonald@g1therapeutics.com