G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today provided a corporate and financial update for the
first quarter ended March 31, 2024.
“Our focus for 2024 is on developing trilaciclib toward
potential category leadership in triple negative breast cancer and
maximizing the uptake of COSELA in its first indication in
extensive stage small cell lung cancer; we've made progress on both
in the first four months of the year,” said Jack Bailey, Chief
Executive Officer of G1 Therapeutics. “Regarding our clinical
progress, we have two important readouts later this year, the first
of which is an ASCO poster presentation in early June on the mature
results from our Phase 2 trial of trilaciclib in combination with a
TROP2 ADC. This will be followed by the readout of our Phase 3
PRESERVE 2 1L mTNBC trial late in the second quarter of this year.
Regarding COSELA for extensive stage small cell lung cancer, we
remain confident in our annual net sales guidance of $60 to $70
million."
First Quarter
2024 and Recent Highlights
Financial
- Recognized $14.1 Million
in Net COSELA Revenue: Vial volume grew four
percent in the first quarter of 2024 over the prior quarter.
- Cash Runway Extends into the Third Quarter of
2025: G1 ended the first quarter of 2024 with cash, cash
equivalents, and marketable securities of $65.2 million.
Clinical
- Updated Efficacy Results from Phase 2 Trial of
Trilaciclib in Combination with an ADC Accepted for Poster
Presentation at the 2024 ASCO Annual Meeting: In January
2024, the Company provided preliminary data from this Phase 2 trial
in combination with the TROP2 ADC sacituzumab govitecan (SG) in
patients with mTNBC suggesting clinically meaningful improvements
in overall survival among patients receiving trilaciclib with SG
compared to SG alone using historical data from the ASCENT study.
Updated efficacy results will be presented in a poster at the 2024
ASCO Meeting, which is being held from May 31 to June 4, 2024.
- Final Analysis of the Phase 3 PRESERVE 2 Trial in 1L
mTNBC is Estimated to Occur in Late Second Quarter 2024:
The final analysis will be conducted on the intent-to-treat (ITT)
population, which includes the survival events from patients
enrolled in the Ukraine. Based on recent interactions with the U.S.
Food and Drug Administration regarding the inclusion of these
events, the final analysis is now expected late in the second
quarter of 2024. If the pivotal results are positive, the Company
will engage the U.S. Food and Drug Administration ahead of a
supplemental New Drug Application (sNDA) filing for this
indication.
Corporate
- Announced License Agreement for Lerociclib with Pepper
Bio, Inc. (“Pepper Bio”): Pepper Bio will gain exclusive
rights to develop, manufacture, and commercialize lerociclib for
all indications except for certain radioprotectant uses in the US,
Europe, Japan, and all other global markets, excluding the
Asia-Pacific region. Under the terms of the agreement, G1 is
expected to receive upfront payments totaling mid-single digit
millions within 12 months and is eligible to receive a maximum of
$135M upon achievement of development and commercial milestones in
up to three indications. In addition, Pepper Bio will pay G1 a
double-digit royalty on aggregate annual net sales of lerociclib.
(See May 1, 2024 press release here)
First Quarter
2024 Financial Results
As of March 31, 2024, cash, cash equivalents and marketable
securities totaled $65.2 million, compared to $82.2 million as of
December 31, 2023. The Company believes that its current cash
runway is sufficient to fund its operations into the third quarter
of 2025.
Total revenues for the first quarter of 2024 were $14.5 million,
including $14.1 million in net product sales of COSELA and license
revenue of $0.4 million, related to patent and clinical trial costs
reimbursed by EQRx, Simcere, and Genor, compared to $12.9 million
in total revenues in the first quarter of 2023.
Operating expenses for the first quarter of 2024 were $23.5
million, compared to $38.7 million for the first quarter of 2023.
GAAP operating expenses include stock-based compensation expense of
$2.5 million for the first quarter of 2024, compared to $3.8
million for the first quarter of 2023.
Cost of goods sold expense for the first quarter of 2024 was
$1.1 million, compared to $1.5 million for the first quarter of
2023, the decrease was primarily due to a cancellation fee
recognized during the quarter ended March 31, 2023.
Research and development (R&D) expenses for the first
quarter of 2024 were $7.3 million, compared to $15.5 million for
the first quarter of 2023. The decrease in R&D expenses was
primarily due to a decrease in the Company's clinical program
costs.
Selling, general, and administrative (SG&A) expenses for the
first quarter of 2024 were $15.1 million, compared to $21.8 million
for the first quarter of 2023. The decrease in SG&A expenses
was primarily due to decreases in personnel costs,
commercialization activities, and medical affairs.
The net loss for the first quarter of 2024 was $10.2 million,
compared to $27.6 million for the first quarter of 2023. The basic
and diluted net loss per share for the first quarter of 2024 was
$(0.20), compared to $(0.53) for the first quarter of 2023.
2024 Financial Guidance
G1 today reaffirmed its full year 2024 financial guidance. The
Company expects to generate between $60 million and $70 million in
COSELA net revenue in 2024. G1's product revenue guidance is based
on expectations for continued acceleration of sales performance of
COSELA in the U.S. Additionally, the Company believes that its
current cash runway is sufficient to fund its operations into the
third quarter of 2025.
Webcast and Conference Call
G1 will host a webcast and conference call at 8:30 a.m. ET today
to provide a corporate and financial update for the first quarter
ended March 31, 2024.
Please note the following process to access the call via
telephone: To register and receive a dial in number and unique PIN
to access the live conference call, please follow this link to
register online. While not required, it is recommended to join 10
minutes prior to the start of the event. 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 COSELA®
(trilaciclib) for Injection
COSELA (trilaciclib) was approved by the U.S. Food and Drug
Administration on February 12, 2021.
Indication
COSELA® (trilaciclib) is indicated to decrease
the incidence of chemotherapy-induced myelosuppression in adult
patients when administered prior to a platinum/etoposide-containing
regimen or topotecan-containing regimen for extensive-stage small
cell lung cancer.
Important Safety Information
COSELA is contraindicated in patients with a history of serious
hypersensitivity reactions to trilaciclib.
Warnings and precautions include injection-site reactions
(including phlebitis and thrombophlebitis), acute drug
hypersensitivity reactions, interstitial lung disease
(pneumonitis), and embryo-fetal toxicity.
The most common adverse reactions (>10%) were fatigue,
hypocalcemia, hypokalemia, hypophosphatemia, aspartate
aminotransferase increased, headache, and pneumonia.
This information is not comprehensive. Please click here for
full Prescribing Information.
https://www.g1therapeutics.com/cosela/pi/
To report suspected adverse reactions, contact G1 Therapeutics
at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit
www.fda.gov/medwatch.
About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage oncology
biopharmaceutical company whose mission is to develop and deliver
next-generation therapies that improve the lives of those affected
by cancer, including the Company’s first commercial product,
COSELA® (trilaciclib). The Company is also evaluating therapies in
combination with cytotoxic therapies and/or immunotherapy in areas
of high unmet need including triple-negative breast cancer and
extensive stage small cell lung cancer. G1’s goal is to provide
innovative therapeutic advances for people living with cancer. For
additional information, please visit www.g1therapeutics.com and
follow us on X (formerly known as Twitter) @G1Therapeutics and
LinkedIn.
G1 Therapeutics® and the G1 Therapeutics logo
and COSELA® and the COSELA logo are trademarks of
G1 Therapeutics, Inc.
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,"
“could”, “believe,” “goal”, “projections,” "estimate," "intend,"
“indicate,” “potential,” “opportunity,” “suggest,” 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 related
to the timing of results from G1’s ongoing clinical trials and
developing trilaciclib toward potential category leadership in
triple negative breast cancer and maximizing the uptake of COSELA
in its first indication in extensive stage small cell lung cancer,
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 dependence on the commercial success of COSELA
(trilaciclib); the development and commercialization of new drug
products is highly competitive; 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 commercial-stage company;
chemotherapy shortages and market conditions. Our business is
subject to substantial risks and uncertainties, including those
referenced above. Investors, potential investors, and others should
give careful consideration to these risks and uncertainties. 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.
G1 Therapeutics Contacts:
John W. Umstead VChief Financial
Officer919-747-8419jumstead@g1therapeutics.com
Will RobertsCommunications OfficerVice President, Investor
Relations & Corporate Communications919-907-1944
wroberts@g1therapeutics.com
G1 Therapeutics,
Inc.Balance Sheet Data(in thousands)
|
March 31, 2024 |
|
December 31, 2023 |
Cash and cash equivalents and Marketable securities |
$ |
65,186 |
|
|
$ |
82,156 |
|
Working Capital |
$ |
63,236 |
|
|
$ |
85,232 |
|
Total Assets |
$ |
102,026 |
|
|
$ |
121,540 |
|
Accumulated deficit |
$ |
(790,204 |
) |
|
$ |
(779,985 |
) |
Total stockholders'
equity |
$ |
27,739 |
|
|
$ |
35,386 |
|
G1 Therapeutics,
Inc.Condensed Statements of Operations(in
thousands, except share and per share amounts)
|
Three Months Ended March 31, |
|
|
2024 |
|
|
|
2023 |
|
Revenues |
(unaudited) |
Product sales, net |
$ |
14,079 |
|
|
$ |
10,492 |
|
License revenue |
|
397 |
|
|
|
2,454 |
|
Total revenues |
|
14,476 |
|
|
|
12,946 |
|
Operating expenses |
|
|
|
Cost of goods sold |
|
1,079 |
|
|
|
1,459 |
|
Research and development |
|
7,318 |
|
|
|
15,480 |
|
Selling, general and administrative |
|
15,127 |
|
|
|
21,753 |
|
Total operating expenses |
|
23,524 |
|
|
|
38,692 |
|
Loss from operations |
|
(9,048 |
) |
|
|
(25,746 |
) |
Other income (expense) |
|
|
|
Interest income |
|
281 |
|
|
|
716 |
|
Interest expense |
|
(1,978 |
) |
|
|
(3,089 |
) |
Other income (expense) |
|
526 |
|
|
|
524 |
|
Total other income (expense),
net |
|
(1,171 |
) |
|
|
(1,849 |
) |
Loss before income taxes |
|
(10,219 |
) |
|
|
(27,595 |
) |
Income tax expense |
|
— |
|
|
|
— |
|
Net loss |
$ |
(10,219 |
) |
|
$ |
(27,595 |
) |
Net loss per share, basic and
diluted |
$ |
(0.20 |
) |
|
$ |
(0.53 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
52,171,684 |
|
|
|
51,647,934 |
|
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